Posted Tue, 15 Oct 2024 16:03:42 GMT by Elena Cerretini
Considering the new EMA requirement to have an active EMA account and relevant IRIS role for contact person at MAH address and for Commission, in order to choose the most appropriate IRIS role could you please clarify which are the activities that the contact person at MAH address will be called to do/receive on IRIS portal?

Thank you very much
Kind regards
Elena
Posted Tue, 22 Oct 2024 12:22:14 GMT by Caterina Scarpati
Dear Elena,

Please refer to the IRIS guide for applicants and the IRIS guide for registration. Following the move to IRIS, the industry portal will be the only way to receive procedure documents and to share working documents that are needed during the ongoing procedure outside of the gateway submissions.

Best regards,
Caterina

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